Electronic Module and Drug Delivery Device

ABSTRACT

The invention relates to an electronic module for recording information of a drug delivery device, the electronic module comprising at least one connector, wherein at least one connector is adapted to be connected to a port of the drug delivery device and wherein at least one connector is adapted to be connected to a port of a computer. Furthermore, the invention relates to a drug delivery device, comprising a port for connecting to the connector of the electronic module.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/762,488, filed Jul. 22, 2015, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. § 371 of International Application No.PCT/EP2014/051475 filed Jan. 27, 2014, which claims priority to EuropeanPatent Application No. 13153141.0 filed Jan. 29, 2013. The entiredisclosure contents of these applications are herewith incorporated byreference into the present application.

FIELD OF INVENTION

The invention relates to an electronic module for recording informationof a drug delivery device and to a drug delivery device arranged toconnect to the electronic module.

BACKGROUND

Administering an injection is a process which presents a number of risksand challenges for users and healthcare professionals, both mental andphysical.

Injection devices (i.e. devices capable of delivering medicaments from amedication container) typically fall into two categories—manual devicesand auto-injectors.

In a manual device—the user must provide the mechanical energy to drivethe fluid through the needle. This is typically done by some form ofbutton/plunger that has to be continuously pressed by the user duringthe injection. There are numerous disadvantages to the user from thisapproach. If the user stops pressing the button/plunger then theinjection will also stop. This means that the user can deliver anunderdose if the device is not used properly (i.e. the plunger is notfully pressed to its end position). Injection forces may be too high forthe user, in particular if the patient is elderly or has dexterityproblems.

The extension of the button/plunger may be too great. Thus it can beinconvenient for the user to reach a fully extended button. Thecombination of injection force and button extension can causetrembling/shaking of the hand which in turn increases discomfort as theinserted needle moves.

Auto-injector devices aim to make self-administration of injectedtherapies easier for patients. Current therapies delivered by means ofself-administered injections include drugs for diabetes (both insulinand newer GLP-1 class drugs), migraine, hormone therapies,anticoagulants etc.

Auto-injectors are devices which completely or partially replaceactivities involved in parenteral drug delivery from standard syringes.These activities may include removal of a protective syringe cap,insertion of a needle into a patient's skin, injection of themedicament, removal of the needle, shielding of the needle andpreventing reuse of the device. This overcomes many of the disadvantagesof manual devices. Injection forces/button extension, hand-shaking andthe likelihood of delivering an incomplete dose are reduced. Triggeringmay be performed by numerous means, for example a trigger button or theaction of the needle reaching its injection depth. In some devices theenergy to deliver the fluid is provided by a spring. In other devicesthis is achieved by an electromechanical drive. Drug delivery devicesmay be arranged to allow recording information related to the therapysuch as type and volume of a drug and injection time and date.

WO 2009/113060 A2 discloses a portable ambulatory fluid delivery device.The device includes a dispensing unit to dispense therapeutic fluid, thedispensing unit including one or more rechargeable batteries, a housingto retain the one or more rechargeable batteries, a reservoir to containthe therapeutic fluid, a driving mechanism to cause delivery of thetherapeutic fluid from the reservoir to a user's body, and at least oneelectrical connector to be coupled to a recharging unit to directelectrical power received from the recharging unit to recharge the oneor more rechargeable batteries. At least a portion of the housing issecurable to a skin of the user.

SUMMARY

It is an object of the present invention to provide an improvedelectronic module for recording information of a drug delivery deviceand to provide an improved drug delivery device.

The object is achieved by an electronic module according to claim 1 andby a drug delivery device according to claim 12.

Preferred embodiments of the invention are given in the dependentclaims.

According to the invention an electronic module for recordinginformation of a drug delivery device comprises at least one connector,wherein at least one connector is adapted to be connected to a port ofthe drug delivery device and wherein at least one connector is adaptedto be connected to a port of a computer distinct from the port of thedrug delivery device, i.e. the port of the computer and the port of thedrug delivery device are distinctly shaped.

A computer in the context of this application may be any data processingdevice suitable for reading and processing data recorded on theelectronic module, such as a personal computer, laptop, handheld, tabletcomputer or smart phone.

The at least one connector is adapted to be directly connected to theport of the drug delivery device and/or to a port of a blood glucosemeter. The blood glucose meter may likewise be integrated with the drugdelivery device. Furthermore, the same or another one of the at leastone connectors is adapted to interface with the computer via a universalconnection. The drug delivery device and/or the electronic module are/isadapted to record therapy information, such as quantities of drug dialedand/or dispensed, dispense time and date etc., to aid health careprofessionals' understanding of a patient's medicinal requirements. Inconnection with the blood glucose meter the electronic module may beadapted to record blood glucose values and, if applicable, time and dateof performed blood glucose measurements.

The electronic module may comprise a display for displaying informationto a user. The electronic module may be arranged to collect and displayto the user information such as:

-   -   type of drug in the current cartridge 4 (long acting insulin,        short acting insulin, GLP-1, etc.),    -   drug volume remaining in the cartridge 4,    -   use-by date of the drug in the current cartridge 4,    -   sizes and timings of doses of the drug taken,    -   time of next recommended blood glucose test, and    -   number of blood glucose measurement strips remaining.

The drug delivery device and/or blood glucose meter may comprise sensorsfor acquiring this information.

The electronic module aims to reduce the complexity of diabetes care andprovide a complete therapy history for both health care professionalsand patients. The electronic module may be arranged to run on-boardsoftware for displaying the data collected in a clear manner,highlighting trends in the patient's medication. The electronic moduleis arranged as a re-useable device. The electronic module may havestored software allowing it to interface with a computer without losingfunctionality.

The re-useable electronic module also allows the compatible drugdelivery device to be disposable; as a significant amount of complexitycan be removed from the drug delivery device with a limited number ofmetallic components.

The connector of the electronic module may be arranged as a universal orstandard connector, for example in one of the formats USB, USB-B, MiniUSB, Micro USB, IEEE1394, computer serial port (RS232), SD Card, Mini SDCard, Micro SD Card, MultiMediaCard, CompactFlash, Memory Stick, etc.

In an exemplary embodiment the electronic module may comprise oneconnector both adapted to be connected to the port of the drug deliverydevice and adapted to be connected to the port of the computer.

In another exemplary embodiment the electronic module may comprise twoconnectors, wherein a first one of the connectors is adapted to beconnected to the port of the drug delivery device and wherein a secondone of the connectors is adapted to be connected to the port of thecomputer. The first connector may be a customized connector while thesecond connector may be a universal connector.

In an exemplary embodiment the connector may comprise at least one slotor recess adapted to be engaged by a protrusion arranged on the port ofthe drug delivery device. The connector may correspond to a universalconnector except for the slot or recess thus allowing the connector toconnect to both a universal port without a protrusion and to acustomized port having the protrusion. The protrusion in the customizedport however does not allow connection of a universal connector thuspreventing the user from connecting universal devices, for example a USBmemory stick.

In an exemplary embodiment the connector comprises a contact carrierretaining a plurality of electric contacts arranged within a frame,wherein a portion of a space within the frame is empty and dimensionedto allow insertion of a contact carrier of the correspondingly shapedport of the drug delivery device retaining a plurality of electriccontacts for contacting the electric contacts of the connector.

In an exemplary embodiment the slot may be formed in the frame.

In another exemplary embodiment the recess is arranged in the electronicmodule or in the connector behind the contact carrier, e.g. in anotherwise compact part of the connector or electronic module such as ahousing.

In an exemplary embodiment of the plurality of electric contacts islocated so as to allow contacting each electric contact of the port ofthe computer by at least two electric contacts of the connector of theelectronic module and to allow contacting each electric contact of theport of the drug delivery device by one respective electric contact ofthe connector of the electronic module. Thus, the amount of informationtransmittable between the electronic module and the drug delivery deviceis increased without having to provide complex circuitry in the drugdelivery device while still allowing the electronic module to contact auniversal port.

For example, as opposed to a universal connector the contacts in thecustomized connector may be split transversally or longitudinally onceor more thus obtaining a multiple of the number of contacts of theuniversal connector. The port of the drug delivery device would also bemodified to have its electric contacts split transversally orlongitudinally for obtaining a corresponding number of electriccontacts.

In an exemplary embodiment the plurality of electric contacts is locatedso as to allow contacting the electric contacts of the port of thecomputer by a first one of two subsets of the electric contacts of theconnector of the electronic module and to allow contacting each electriccontact of the two subsets by one respective electric contact of theport of the drug delivery device. Thus, the amount of informationtransmittable between the electronic module and the drug delivery deviceis increased without having to provide complex circuitry in the drugdelivery device while still allowing the electronic module to contact auniversal port.

In an exemplary embodiment the electric contacts of the first subset arenarrower than the electric contacts of the port of the computer, whereineach contact of a second one of the two subsets is arranged between twocontacts of the first subset. The electric contacts of the second subsetare preferably arranged such that they do not contact the electriccontacts of the port of the computer but insulated areas between theelectric contacts of the port of the computer.

In an exemplary embodiment the electric contacts of the first subset arearranged on a first plane of the contact carrier and the electriccontacts of the second subset are arranged on at least one further planeof the contact carrier. The electric contacts of the first subset on thefirst plane are arranged to contact both, corresponding electriccontacts in the ports of the computer and the drug delivery device whilethe electric contacts of the second subset on the further plane arearranged to contact corresponding electric contacts on a correspondingplane of the contact carrier in the port of the drug delivery deviceonly. This corresponding plane of the port of the drug delivery devicealso distinguishes the port from a universal port and preventsconnecting it to a universal connector.

According to another aspect of the invention a drug delivery devicecomprises a port for connecting to a connector of an electronic moduleaccording to the invention for recording information of a drug deliverydevice.

In an exemplary embodiment the port comprises at least one protrusionadapted to engage a slot or recess in the connector of the electronicmodule.

In an exemplary embodiment the port comprises a contact carrierretaining a plurality of electric contacts arranged within a frame,wherein a portion of a space within the frame is empty and dimensionedto allow insertion of a contact carrier of the correspondingly shapedconnector of the electronic module retaining a plurality of electriccontacts for contacting the electric contacts of the port.

In an exemplary embodiment a gap is provided between the contact carrierand the frame of the port to allow insertion of the frame of theconnector.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus, are not limitiveof the present invention, and wherein:

FIG. 1 is a schematic view of a drug delivery device and an electronicmodule,

FIG. 2 is a schematic perspective view of another exemplary embodimentof the electronic module and a corresponding drug delivery device,

FIG. 3 is a schematic perspective view of an exemplary embodiment of theelectronic module having a connector with a slot,

FIG. 4 is a schematic view of a drug delivery device with a port havinga protrusion for engaging the slot of the connector of the electronicmodule of FIG. 3 ,

FIG. 5 is a detail side view of an exemplary embodiment of theelectronic module having a connector with two slots,

FIG. 6 is a detail side view of an exemplary embodiment of theelectronic module having a connector with three slots,

FIG. 7 is a perspective view of an exemplary embodiment of theelectronic module, wherein a recess is arranged in the electronic modulebehind the connector,

FIG. 8 is a perspective detail view of an exemplary embodiment of thedrug delivery device with a port having a protrusion for engaging therecess of the connector of the electronic module of FIG. 7 ,

FIG. 9 is a perspective view of an exemplary embodiment of theelectronic module having a bespoke or customized first connector and auniversal second connector,

FIG. 10 is a perspective view of another exemplary embodiment of theelectronic module having a bespoke or customized first connector and auniversal second connector,

FIG. 11 is a schematic sectional view of an exemplary embodiment of theelectronic module with a modified connector,

FIG. 12 is a schematic sectional view of another exemplary embodiment ofthe electronic module with a modified connector,

FIG. 13 is a schematic sectional view of yet another exemplaryembodiment of the electronic module with a modified connector,

FIG. 14 is a schematic sectional view of yet another exemplaryembodiment of the electronic module with a modified connector, and

FIG. 15 is a schematic sectional view of yet another exemplaryembodiment of the electronic module with a modified connector having acontact carrier with two different horizontal planes.

Corresponding parts are marked with the same reference symbols in allfigures.

DETAILED DESCRIPTION

FIG. 1 shows a drug delivery device 1 and an electronic module 2.

The drug delivery device 1 comprises a body 3 adapted to receive a drugcartridge 4 or syringe having or adapted to be connected to a hypodermicinjection needle 5 or needle arrangement. Furthermore, the drug deliverydevice 1 comprises a port 6 for interfacing with the electronic module2.

The electronic module 2 comprises a connector 7 adapted to be directlyconnected to the port 6 of the drug delivery device 1 and/or to a portof a blood glucose meter (not illustrated). The blood glucose meter maylikewise be integrated with the drug delivery device 1. Furthermore, theelectronic module 2 is adapted to interface with a computer, such as aPC or Laptop via a universal connection. The drug delivery device 1and/or the electronic module 2 are/is adapted to record therapyinformation, such as quantities of drug dialed and/or dispensed,dispense time and date etc., to aid health care professionals'understanding of a patient's medicinal requirements. In connection withthe blood glucose meter the electronic module 2 is adapted to recordblood glucose values and, if applicable, time and date of performedblood glucose measurements.

The electronic module 2 is adapted to record the date and time of anytreatment related activity, in addition to recording the blood glucosereading or the drug dose size taken.

The electronic module 2 comprises a display 8 for displaying informationto a user. The electronic module 2 may be arranged to collect anddisplay to the user information such as:

-   -   type of drug in the current cartridge 4 (long acting insulin,        short acting insulin, GLP-1, etc.),    -   drug volume remaining in the cartridge 4,    -   use-by date of the drug in the current cartridge 4,    -   time of next recommended blood glucose test, and    -   number of blood glucose measurement strips remaining.

The drug delivery device 1 may comprise sensors for acquiring thisinformation.

The electronic module 2 aims to reduce the complexity of diabetes careand provide a complete therapy history for both health careprofessionals and patients. The electronic module 2 may be arranged torun on-board software for displaying the data collected in a clearmanner, highlighting trends in the patient's medication. The electronicmodule 2 is arranged as a re-useable device. The electronic module 2 mayhave stored software allowing it to interface with any computationaldevice such as a computer, e.g. a PC or laptop, without losingfunctionality.

The re-useable electronic module 2 also allows the compatible drugdelivery device 1 to be disposable; as a significant amount ofcomplexity can be removed from the drug delivery device 1 with a limitednumber of metallic components.

The connector 7 of the electronic module 2 may be arranged as auniversal or standard connector, for example in one of the formats USB,USB-B, Mini USB, Micro USB, IEEE1394, computer serial port (RS232), or astandard or proprietary connector of a flash memory card, such as SDCard, Mini SD Card, Micro SD Card, MultiMediaCard, CompactFlash, MemoryStick, and/or the like.

FIG. 1 is a schematic perspective view of an exemplary embodiment of theelectronic module 2 and a corresponding drug delivery device 1. Theelectronic module 2 is adapted to be laterally arranged on the body 3 ofthe drug delivery device 1 and interface to the port 6 in a rear end ofthe drug delivery device 1 such that the drug delivery device 1 and theelectronic module 2 form an ergonomic and functional unit whenconnected.

FIG. 2 is a schematic perspective view of another exemplary embodimentof the electronic module 2 and a corresponding drug delivery device 1.The electronic module 2 is shaped as a button and arranged to beassembled to a rear end of the drug delivery device 1 such that the drugdelivery device 1 and the electronic module 2 form an ergonomic andfunctional unit when connected.

The electronic module 2 preferably comprises a connector 7, such as aUSB connector, to have the ability to directly interface with anycomputer having a universal port. If the same connector 7 is used toconnect to the drug delivery device 1 and/or a blood glucose meter theports 6 of these devices should comply with the same standard as theconnector 7, e.g. USB. This may result in attempts of the user toassemble generic devices of this standard, e.g. USB sticks, to the drugdelivery device 1. This should be avoided in order to ensure users donot think data is being recorded when a generic device is connected andto avoid potential data corruption.

In order to address this problem the electronic module 2 and the drugdelivery device 1 may be modified as illustrated in FIGS. 3 to 10 .

FIG. 3 is a schematic perspective view of an exemplary embodiment of theelectronic module 2. FIG. 4 is a schematic view of a corresponding drugdelivery device 1. The connector 7 substantially complies with astandard form such as USB. In this case the connector 7 comprises acontact carrier 7.1 retaining four electric contacts 7.2 arranged withina connector frame 7.3, which may be rectangular and comprise or consistof sheet metal. The electric contacts 7.2 are accessible through anopening in the connector frame 7.3. The contact carrier 7.1 and theelectric contacts 7.2 fill only a portion of the space within theconnector frame 7.3 while another portion 7.4 is empty.

The port 6 on the drug delivery device 1 likewise comprises a contactcarrier 6.4 which corresponds to empty portion 7.4 of the connector 7.The contact carrier 6.4 retains four electric contacts 6.2 arrangedwithin an empty connector frame 6.3 within body 3. The empty connectorframe 6.3 corresponds to and is configured to receive connector frame7.3 of the connector 7. Empty connector frame 7.3 may be rectangular andbe shielded by sheet metal. The electric contacts 6.2 are accessiblethrough an opening in the connector frame 6.3. The contact carrier 6.4and the electric contacts 6.2 fill only a portion of the space withinthe connector frame 6.3 while another portion 6.1 is empty. Theconnector frame 6.3 of the port 6 is dimensioned to allow insertion ofthe connector frame 7.3 of the connector 7 wherein the contact carrier7.1 of the connector 7 enters the empty portion 6.1 within the connectorframe 6.3 of the port 6 while the contact carrier 6.4 of the port 6enters the empty portion 7.4 within the connector frame 7.3 of theconnector 7 such that each electric contact 6.2 of the port 6 contacts arespective electric contact 7.2 of the connector 7.

In order to ensure only the correct electronic module 2 is connected tothe drug delivery device 1 at least one slot 7.5 is cut into theconnector frame 7.3 of the connector 7 on the electronic module 2. Theport 6 on the drug delivery device 1 and/or on the blood glucose metercomprises a protrusion 6.5 arranged to engage the slot 7.5. Theprotrusion 6.5 may be part of the body 3 protruding through a slot intothe connector frame 7.3. The protrusion 6.5 in the port 6 blocks thefitting of a standard connector while the slot 7.5 in the modifiedconnector 7 does not prevent fitting to standard ports 6.

In alternative embodiments the connector 7 of the electronic module 2may have more than one slot 7.5 and the port 6 of the drug deliverydevice 1 may have a corresponding number of protrusions 6.5.

FIG. 5 is a detail side view of an exemplary embodiment of theelectronic module 2 having a connector 7 with two slots 7.5.

FIG. 6 is a detail side view of an exemplary embodiment of theelectronic module 2 having a connector 7 with three slots 7.5.

In alternative embodiments the connector 7 of the module 2 may compriseat least one different recess feature for interfacing with acorresponding protrusion on the port 6 of the drug delivery device 1.

FIG. 7 is a perspective view of an exemplary embodiment of theelectronic module 2, wherein a recess 7.6 is arranged in the electronicmodule 2 behind the connector 7. FIG. 8 is a perspective detail view ofan exemplary embodiment of the drug delivery device 1, wherein aprotrusion 6.5 passing through and extending from the connector frame6.3 of the port 6 is arranged to engage in the recess 7.6 of theelectronic module 2 in the electronic module 2 behind the connector 7.The protrusion 6.5 on the port 6 blocks the fitting of a standardconnector while the recess 7.6 in the modified connector 7 does notprevent fitting to standard ports 6.

Another option for preventing the user from assembling generic devicesto the drug delivery device 1 is illustrated in FIGS. 9 and 10 .

FIG. 9 is a perspective view of an exemplary embodiment of theelectronic module 2 having a bespoke or customized first connector 7adapted to interface with a correspondingly shaped port in the drugdelivery device (not illustrated) and a universal second connector 7′adapted to interface with universal ports in other equipment such as acomputer. The electronic module 2 is suitable to be laterally arrangedon the body 3 of a drug delivery device 1 similar to the one illustratedin FIG. 1 and interface with the first connector 7 to the port 6 in arear end of the drug delivery device 1 such that the drug deliverydevice 1 and the electronic module 2 form an ergonomic and functionalunit when connected. The connectors 7, 7′ are arranged on opposed endsof the electronic module 2.

FIG. 10 is a perspective view of an exemplary embodiment of theelectronic module 2 having a bespoke or customized first connector 7adapted to interface with a correspondingly shaped port in the drugdelivery device (not illustrated) and a universal second connector 7′adapted to interface with universal ports in other equipment such as acomputer. The electronic module 2 is shaped as a button and suited to beassembled to a rear end of a drug delivery device 1 similar to the oneillustrated in FIG. 2 such that the drug delivery device 1 and theelectronic module 2 form an ergonomic and functional unit whenconnected. The first connector 7 is arranged on an end of the electronicmodule 2 arranged to connect to the drug delivery device 1 while thesecond connector 7′ is aligned at right angles relative to the firstconnector 7.

A dose size delivered or to be delivered may be acquired and encoded sothat it can be stored and processed by the electronic module 2.Acquisition and encoding of the dose size has to be performed within thedrug delivery device 1, e.g. by means of mechanical contacts. In orderto encode an 80 unit dose 7 bits and accordingly 7 contacts are neededas 80 is greater than 26=64 but smaller than 27=128. However, theconnectors 7 of the electronic module 2 described above comply with theUSB standard and therefore comprise four electric contacts 7.2 thuslimiting the number of units that can be transferred from the drugdelivery device 1 to the electronic module 2 without further circuitryin the drug delivery device 1 to 24=16. Transferring a wider range ofunit values over the port 6 may be achieved by serializing the acquiredvalues by respective circuitry in the drug delivery device 1. However,it may be preferred to arrange the drug delivery device 1 as adisposable device wherein as much of the electronic circuitry aspossible would be arranged in the reusable electronic module 2 to reducethe cost of the drug delivery device 1. In this situation the injectiondevice would preferably have no or as little circuitry as possible andcomprise conductive track and contact arms, which could be connected tothe circuitry in the electronic module 2 via the port 6 and theconnector 7. In this case transferring a wider range of values requiresa greater number of electric contacts 6.2, 7.2.

For example in order to encode an 80 unit dose 7 bits and accordingly 7contacts are needed as 80 is greater than 26=64 and smaller than 27=128.

In order to address this problem the connector 7 may be modified asillustrated in FIGS. 11 to 15 .

FIG. 11 is a schematic sectional view of an exemplary embodiment of theelectronic module 2 with a modified connector 7. As opposed to theembodiments of FIGS. 3 and 7 which have four electric contacts 7.2 thecontacts 7.2 in the embodiment of FIG. 11 are split transversally thusobtaining eight electric contacts 7.2. The port 6 of the drug deliverydevice 1 would also be modified to have eight corresponding electriccontacts 6.2.

FIG. 12 is a schematic sectional view of an exemplary embodiment of theelectronic module 2 with a modified connector 7. As opposed to theembodiments of FIGS. 3 and 7 which have four electric contacts 7.2 thecontacts 7.2 in the embodiment of FIG. 12 are split twice transversallythus obtaining twelve electric contacts 7.2. The port 6 of the drugdelivery device 1 would also be modified to have twelve correspondingelectric contacts 6.2.

FIG. 13 is a schematic sectional view of an exemplary embodiment of theelectronic module 2 with a modified connector 7. As opposed to theembodiments of FIGS. 3 and 7 which have four electric contacts 7.2 thecontacts 7.2 in the embodiment of FIG. 13 are split longitudinally thusobtaining eight electric contacts 7.2. The port 6 of the drug deliverydevice 1 would also be modified to have eight corresponding electriccontacts 6.2.

The electric contacts 7.2, 6.2 could be split more than twice thusobtaining 16 or another multiple of the number of electric contacts 7.2,6.2 of the generic universal connector. This solution may be applied toother connectors 7 having a different generic number of electriccontacts 7.2. The number of obtainable electric contacts 7.2 would thenbe a multiple of the generic number.

FIG. 14 is a schematic sectional view of an exemplary embodiment of theelectronic module 2 with a modified connector 7. As opposed to theembodiments of FIGS. 3 and 7 which have four relatively wide electriccontacts 7.2 in a first subset 7.8 of the generic electric contacts 7.2in the embodiment of FIG. 14 the electric contacts 7.2 are narrowed andadditional electric contacts 7.2 of a second subset 7.9 are arrangedbetween the generic ones of the first subset 7.8 thus obtaining sevenelectric contacts 7.2. The port 6 of the drug delivery device 1 wouldalso be modified to have seven corresponding electric contacts 6.2. Inthis solution, additional electric contacts 7.2 are placed in a regionoutside the standard four contact zones.

FIG. 15 is a schematic sectional view of an exemplary embodiment of theelectronic module 2 with a modified connector 7. As opposed to theembodiments of FIGS. 3 and 7 which have four relatively wide electriccontacts 7.2 arranged on the contact carrier 7.1 in one plane themodified connector 7 in FIG. 15 comprises a contact carrier 7.1 with twodifferent horizontal planes 7.7 on which four electric contacts 7.2 of afirst subset 7.8 and a second subset 7.9, are arranged, respectivelythus obtaining eight electric contacts 7.2. The port 6 of the drugdelivery device 1 would also be modified to have a contact carrier 6.4with two different planes and eight electric contacts 6.2 correspondingto the electric contacts 7.2 of the modified connector 7. The modifiedcontact carrier 6.4 of the port 6 would thus also block fitting of ageneric connector to the drug delivery device 1.

The connectors 7 modified according to one of the FIGS. 11 to 15 wouldstill allow to connect to a standard (USB) port of a computer.

The term “drug” or “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

-   -   wherein in one embodiment the pharmaceutically active compound        has a molecular weight up to 1500 Da and/or is a peptide, a        proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme,        an antibody or a fragment thereof, a hormone or an        oligonucleotide, or a mixture of the above-mentioned        pharmaceutically active compound,    -   wherein in a further embodiment the pharmaceutically active        compound is useful for the treatment and/or prophylaxis of        diabetes mellitus or complications associated with diabetes        mellitus such as diabetic retinopathy, thromboembolism disorders        such as deep vein or pulmonary thromboembolism, acute coronary        syndrome (ACS), angina, myocardial infarction, cancer, macular        degeneration, inflammation, hay fever, atherosclerosis and/or        rheumatoid arthritis,    -   wherein in a further embodiment the pharmaceutically active        compound comprises at least one peptide for the treatment and/or        prophylaxis of diabetes mellitus or complications associated        with diabetes mellitus such as diabetic retinopathy,    -   wherein in a further embodiment the pharmaceutically active        compound comprises at least one human insulin or a human insulin        analogue or derivative, glucagon-like peptide (GLP-1) or an        analogue or derivative thereof, or exendin-3 or exendin-4 or an        analogue or derivative of exendin-3 or exendin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

-   -   H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,    -   H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,    -   des Pro36 Exendin-4(1-39),    -   des Pro36 [Asp28] Exendin-4(1-39),    -   des Pro36 [IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),    -   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or    -   des Pro36 [Asp28] Exendin-4(1-39),    -   des Pro36 [IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),    -   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),    -   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),    -   wherein the group -Lys6-NH2 may be bound to the C-terminus of        the Exendin-4 derivative;    -   or an Exendin-4 derivative of the sequence    -   des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),    -   H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,    -   des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,    -   H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,    -   H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,    -   des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,    -   H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]        Exendin-4(1-39)-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]        Exendin-4(1-39)-NH2,    -   des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,    -   des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,    -   H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-NH2,    -   des Pro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]        Exendin-4(1-39)-Lys6-NH2,    -   H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]        Exendin-4(1-39)-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]        Exendin-4(1-39)-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,        Asp28] Exendin-4(1-39)-NH2,    -   des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]        Exendin-4(1-39)-(Lys)6-NH2,    -   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]        Exendin-4(S1-39)-(Lys)6-NH2,    -   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25,        Asp28] Exendin-4(1-39)-(Lys)6-H2;    -   or a pharmaceutically acceptable salt or solvate of any one of        the afore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (˜150 kDa) that are also knownas immunoglobulins which share a basic structure. As they have sugarchains added to amino acid residues, they are glycoproteins. The basicfunctional unit of each antibody is an immunoglobulin (Ig) monomer(containing only one Ig unit); secreted antibodies can also be dimericwith two Ig units as with IgA, tetrameric with four Ig units liketeleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a “Y”-shaped molecule that consists of fourpolypeptide chains; two identical heavy chains and two identical lightchains connected by disulfide bonds between cysteine residues. Eachheavy chain is about 440 amino acids long; each light chain is about 220amino acids long. Heavy and light chains each contain intrachaindisulfide bonds which stabilize their folding. Each chain is composed ofstructural domains called Ig domains. These domains contain about 70-110amino acids and are classified into different categories (for example,variable or V, and constant or C) according to their size and function.They have a characteristic immunoglobulin fold in which two β sheetscreate a “sandwich” shape, held together by interactions betweenconserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ,and μ. The type of heavy chain present defines the isotype of antibody;these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies,respectively.

Distinct heavy chains differ in size and composition; α and γ containapproximately 450 amino acids and δ approximately 500 amino acids, whileμ and ε have approximately 550 amino acids. Each heavy chain has tworegions, the constant region (C_(H)) and the variable region (V_(H)). Inone species, the constant region is essentially identical in allantibodies of the same isotype, but differs in antibodies of differentisotypes. Heavy chains γ, α and δ have a constant region composed ofthree tandem Ig domains, and a hinge region for added flexibility; heavychains μ and ε have a constant region composed of four immunoglobulindomains. The variable region of the heavy chain differs in antibodiesproduced by different B cells, but is the same for all antibodiesproduced by a single B cell or B cell clone. The variable region of eachheavy chain is approximately 110 amino acids long and is composed of asingle Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted byλ and κ. A light chain has two successive domains: one constant domain(CL) and one variable domain (VL). The approximate length of a lightchain is 211 to 217 amino acids. Each antibody contains two light chainsthat are always identical; only one type of light chain, κ or λ, ispresent per antibody in mammals.

Although the general structure of all antibodies is very similar, theunique property of a given antibody is determined by the variable (V)regions, as detailed above. More specifically, variable loops, threeeach the light (VL) and three on the heavy (VH) chain, are responsiblefor binding to the antigen, i.e. for its antigen specificity. Theseloops are referred to as the Complementarity Determining Regions (CDRs).Because CDRs from both VH and VL domains contribute to theantigen-binding site, it is the combination of the heavy and the lightchains, and not either alone, that determines the final antigenspecificity.

An “antibody fragment” contains at least one antigen binding fragment asdefined above, and exhibits essentially the same function andspecificity as the complete antibody of which the fragment is derivedfrom. Limited proteolytic digestion with papain cleaves the Ig prototypeinto three fragments. Two identical amino terminal fragments, eachcontaining one entire L chain and about half an H chain, are the antigenbinding fragments (Fab). The third fragment, similar in size butcontaining the carboxyl terminal half of both heavy chains with theirinterchain disulfide bond, is the crystalizable fragment (Fc). The Fccontains carbohydrates, complement-binding, and FcR-binding sites.Limited pepsin digestion yields a single F(ab′)2 fragment containingboth Fab pieces and the hinge region, including the H-H interchaindisulfide bond. F(ab′)2 is divalent for antigen binding. The disulfidebond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, thevariable regions of the heavy and light chains can be fused together toform a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the apparatuses, methodsand/or systems and embodiments described herein may be made withoutdeparting from the full scope and spirit of the present invention, whichencompass such modifications and any and all equivalents thereof.

1. Electronic module (2) for recording information of a drug deliverydevice (1), the electronic module (2) comprising at least one connector(7, 7′), wherein at least one connector (7, 7′) is adapted to beconnected to a port (6) of the drug delivery device (1) and wherein atleast one connector (7, 7′) is adapted to be connected to a port of acomputer distinct from the port of the drug delivery device (1). 2.Electronic module (2) according to claim 1, comprising one connector (7,7′) adapted to be connected to the port (6) of the drug delivery device(1) and adapted to be connected to the port of the computer. 3.Electronic module (2) according to claim 1, comprising two connectors(7, 7′), wherein a first one of the connectors (7) is adapted to beconnected to the port (6) of the drug delivery device (1) and wherein asecond one of the connectors (7′) is adapted to be connected to the portof the computer.
 4. Electronic module (2) according to claim 2, whereinthe connector (7, 7′) comprises at least one slot (7.5) or recess (7.6)adapted to be engaged by a protrusion (6.5) arranged on the port (6) ofthe drug delivery device (1).
 5. Electronic module (2) according toclaim 4, wherein the connector (7) comprises a contact carrier (7.1)retaining a plurality of electric contacts (7.2) arranged within a frame(7.3), wherein a portion (7.4) of a space within the frame (7.3) isempty and dimensioned to allow insertion of a contact carrier (6.4) ofthe correspondingly shaped port (6) of the drug delivery device (1)retaining a plurality of electric contacts (6.2) for contacting theelectric contacts (7.2) of the connector (7).
 6. Electronic module (2)according to claim 5, wherein the slot (7.5.) is formed in the frame(7.3).
 7. Electronic module (2) according to claim 5, wherein the recess(7.6) is arranged in the electronic module (2) or in the connector (7)behind the contact carrier (7.1).
 8. Electronic module (2) according toone of the claims 5 to 7, wherein the plurality of electric contacts(7.2) is located so as to allow contacting each electric contact of theport of the computer by at least two electric contacts (7.2) of theconnector (7) of the electronic module (2) and to allow contacting eachelectric contact (6.2) of the port (6) of the drug delivery device (1)by one respective electric contact (7.2) of the connector (7) of theelectronic module (2).
 9. Electronic module (2) according to one of theclaims 5 to 7, wherein the plurality of electric contacts (7.2) islocated so as to allow contacting the electric contacts of the port ofthe computer by a first one (7.8) of two subsets (7.8, 7.9) of theelectric contacts (7.2) of the connector (7) of the electronic module(2) and to allow contacting each electric contact (7.2) of the twosubsets (7.8, 7.9) by one respective electric contact (6.2) of the port(6) of the drug delivery device (1).
 10. Electronic module (2) accordingto claim 9, wherein the electric contacts (7.2) of the first subset(7.8) are narrower than the electric contacts of the port of thecomputer, wherein each electric contact (7.2) of a second one (7.9) ofthe two subsets (7.8, 7.9) is arranged between two contacts (7.2) of thefirst subset (7.8).
 11. Electronic module (2) according to claim 9,wherein the electric contacts (7.2) of the first subset (7.8) arearranged on a first plane (7.7) of the contact carrier (7.1) and whereinthe electric contacts (7.2) of the second subset (7.9) are arranged onat least one further plane (7.7) of the contact carrier (7.1).
 12. Drugdelivery device (1), comprising a port (6) for connecting to a connector(7) of an electronic module (2) according to one of the claims 1 to 11for recording information of the drug delivery device (1).
 13. Drugdelivery device (1) according to claim 12, wherein the port comprises atleast one protrusion (6.5) adapted to engage a slot (7.5) or recess(7.6) in the connector (7) of the electronic module (2).
 14. Drugdelivery device (1) according to one of the claim 12 or 13, wherein theport (6) comprises a contact carrier (6.4) retaining a plurality ofelectric contacts (6.2) arranged within a frame (6.3), wherein a portion(6.1) of a space within the frame (6.3) is empty and dimensioned toallow insertion of a contact carrier (7.1) of the correspondingly shapedconnector (7) of the electronic module (2) retaining a plurality ofelectric contacts (7.2) for contacting the electric contacts (6.2) ofthe port (6).